BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BATTERY POWERDRIVER P2

    MDR report key: 12540309 · Received September 28, 2021

    Report

    Report Number
    0001032347-2021-00457
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Report Date
    February 10, 2022
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GEY
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. THE POWER DRIVER BATTERY IS A SINGLE-USE ITEM THAT COMES PRE-STERILIZED. THIS BATTERY IS OPENED ON THE BACK TABLE PRIOR TO THE PATIENT ENTERING THE OR AS A PART OF THE INITIAL ROOM SET UP. IF AN ADDITIONAL BATTERY IS NEEDED DURING THE PROCEDURE, THE CIRCULATOR WILL OPEN THE PACKAGE TO THE SCRUB AT THE BACK TABLE. THE PACKAGES ARE INSPECTED PRIOR TO OPENING, AND IF DEBRIS IS IDENTIFIED IN THE PACKAGE, THE PRODUCT IS NOT USED. AS THERE IS NO PATIENT INVOLVEMENT, THERE IS NO CONCERN FOR PATIENT IMPACT (FROM AN OR PERSPECTIVE). PRODUCT IS 100% INSPECTED PRIOR TO RELEASE FROM ZIMMER BIOMET. ALLEGATIONS ARE FOUND IN A DISTRIBUTOR'S INCOMING INSPECTION AND NOT INVOLVED IN A PROCEDURE - INSPECTION CRITERIA MAY DIFFER FROM ZB'S INTERNAL CRITERIA.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: FLAT TITANIUM PECTUS BAR 11" ,CAT# JP-0110, LOT# 283130; L-PLT LT REG 2.0 LACTOSORB SYS ,CAT# 915-2102, LOT# 638640; BATTERY POWERDRIVER P2, CAT# 50-1010 ,LOT# 282330; BATTERY POWERDRIVER P2, CAT#50-1010, LOT# 282320; BATTERY POWERDRIVER P2, CAT#50-1010, LOT# 476000; BATTERY POWERDRIVER P2, CAT#50-1010, LOT# 579610; CARROLL-GIRARD SCREW HEX-END ,CAT# SP-2693, LOT# 818880; LACTO SCR 1.5X4MM 1.5 SYS 2PK, CAT# 915-2315, LOT# 727800; LACTOSORB1.5MM XSHAPEEXTPLATE, CAT# 915-2423, LOT# 832560; BATTERY POWERDRIVER P2 ,CAT# 50-1010, LOT# 692220; BATTERY POWERDRIVER P2 ,CAT# 50-1010, LOT# 692220; BATTERY POWERDRIVER P2 ,CAT# 50-1010, LOT# 003430; BATTERY POWERDRIVER P2 ,CAT# 50-1010, LOT# 003380; BATTERY POWERDRIVER P2 ,CAT# 50-1010, LOT# 760440; BATTERY POWERDRIVER P2 ,CAT# 50-1010, LOT# 657440; BATTERY POWERDRIVER P2 , CAT# 50-1010, LOT# 657440. BATTERY POWERDRIVER P2, CAT# 50-1010, LOT# 760510; BATTERY POWERDRIVER P2, CAT# 50-1010 ,LOT# 760350; PLATE 4 HOLE WITH GAP 2.0MM, CAT# SP-2292, LOT# 480680; STER TRC TF 18.5MM BNT BUR PL, CAT# SP-ST-1020B ,LOT# 147140; STER TRC 2 XD TF 1.5X4.0MM SCR, CAT# SP-ST2-6704 ,LOT# 071120; LACTO SCR 1.5X5MM 1.5 SYS 2PK, CAT# 915-2316 ,LOT# 728470. REPORT SOURCE: FOREIGN COUNTRY: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347 - 2021 - 00441, 0001032347 - 2021 - 00442, 0001032347 - 2021 - 00443, 0001032347 - 2021 - 00444, 0001032347 - 2021 - 00445, 0001032347 - 2021 - 00446, 0001032347 - 2021 - 00447, 0001032347 - 2021 - 00448, 0001032347 - 2021 - 00449, 0001032347 - 2021 - 00450, 0001032347 - 2021 - 00451, 0001032347 - 2021 - 00452, 0001032347 - 2021 - 00453, 0001032347 - 2021 - 00454, 0001032347 - 2021 - 00455, 0001032347 - 2021 - 00456, 0001032347 - 2021 - 00458, 0001032347 - 2021 - 00459, 0001032347 - 2021 - 00460, 0001032347 - 2021 - 00461, 0001032347 - 2021 - 00462, 0001032347 - 2021 - 00463.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS FOREIGN MATERIAL FOUND WITHIN STERILE PACKAGING DURING INCOMING INSPECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436736 BATTERY POWERDRIVER P2 MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY BIOMET MICROFIXATION NI 657440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown